# K083320: Dukal Surgical Drape; Fenestrated Dukal Surgical Drape

- Pathway: 510(k) (Traditional)
- Applicant: Dukal Corp.
- Decided: Mar 6, 2009 after 114 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K140195: Surgical Drape (2014), 0 descendants of its own

## Indications for use
The Dukal 20-001 - Fenestrated Dukal Surgical Drape, Blue, 18" x 26", with 3" Fenestration, and 20-002 - Dukal Surgical Drape, Blue, 18" x 26" is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Source page: https://510kreport.com/device/K083320
Methodology: https://510kreport.com/methodology